On Technical Requirements For Marine Equipment

Original Language Title: o technických požadavcích na námořní zařízení

Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=69145&nr=266~2F2009~20Sb.&ft=txt

266/2009 Sb.



GOVERNMENT REGULATION



of 27 June. July 2009



on technical requirements for marine equipment



Change: 101/2010 Sb.



Change: 228/2006.



Change: 335/2009 Sb.



Government orders under section 22 of Act No. 22/1997 Coll., on technical

requirements for products and amending and supplementing certain acts, as amended by

Act No. 207/2002 Coll. (hereinafter the "Act") to implement section 11 para. 2, §

11A. 2, section 12 and 13 of the Act:



§ 1



(1) this regulation incorporates the relevant provisions of the European Union ^ 1) and

laying down technical requirements for equipment intended for use on board

sea-going vessels ^ 2), which are listed in annex 1 to this

Regulation (hereinafter referred to as "marine equipment"). Marine equipment are

established products within the meaning of § 12 para. 1 (b). and) of the Act.



(2) this Regulation shall not apply to marine equipment intended for use on

Board the warships.



§ 2



In this regulation, the radiocommunications equipment means equipment referred to

in chapter IV. The International Convention for the safety of life at sea

1974 ^ 3) (hereinafter referred to as "SOLAS") and two-way radiotelephone

appliance VHF survival craft.



§ 3



(1) marine equipment shall meet the requirements set out in annex 1 to the

application of this regulation.



(2) compliance with the requirements referred to in paragraph 1 shall be determined in accordance with procedures

testing standards and conformity assessment procedures set out in annex 1 to the

application of this regulation.



(3) the contents of the various conformity assessment procedures is given in annex No.

2 to this regulation.



(4) the requirements of other legislation on marine equipment, for the purposes

the conformity assessment shall not be used.



§ 4



(1) For the assessment of conformity of marine equipment authorization may be granted

pursuant to section 11 of the Act to the legal entity that meets the requirements set out in annex

# 3, to this regulation.



(2) Office for standards, metrology and testing

at least once every two years, runs in accordance with § 11 para. 4 control activities

the notified body, if it meets the criteria referred to in annex 3 to this

of the regulation.



(3) if part A of annex 2 to this regulation allows to execute

a specific part of a conformity assessment procedure through another person, must

This person meet the same requirements as notified body.



§ 5



(1) marine equipment, which is intended to be placed on board a sea

the vessel, or that is placed on board, must be provided with

mark of conformity, unless otherwise provided in this regulation.



(2) the manufacturer or his authorised representative shall affix the mark of conformity

marine equipment, which meets the requirements referred to in annex 1 to the

of this regulation and whose compliance was verified by the relevant

conformity assessment. Mark of conformity with the marine equipment provides at the end of

the production phase.



(3) for the mark of conformity shall be notified body, the manufacturer or his

authorized representative identification number of the notified body which

carried out the conformity assessment procedure, if it is involved in the control phase

production, and the last two digits of the year in which the maritime

the conformity mark is affixed.



(4) marine equipment or to its data plate must bear the

matches always in a visible, legible and indelible manner, and that all the

the lifetime of the device. If this is not technically possible, glue

mark of conformity to the product packaging or the leaflet.



(5) the marine equipment, its a descriptive label, package or leaflet must not be

bear the inscription, or which can be confused with the brand

of conformity.



(6) the graphical representation of the mark of conformity is given in annex 4 to this

of the regulation.



§ 6



(1) if it is found that the marine equipment bearing the mark

compliance, may endanger the safety and health of persons, property or the sea

environment, even if they are properly installed, maintained and used in the

accordance with its intended purpose, such a facility may be saved

protective measures under other legislation ^ 4).



(2) in the case that was for naval equipment saved a safeguard measure

in accordance with paragraph 1, it shall be indicated in the notification of the decision on the imposition of safeguard

measures pursuant to § 7 (2). 8 of the Act, whether the non-compliance was caused by



and the failure to satisfy the requirements laid down in) Annex 1 to this regulation,



b) incorrect application of the testing standards referred to in § 3 (1). 2, or



c) shortcomings in the testing standards referred to in § 3 (1). 2.



§ 7



(1) it is necessary to replace the marine equipment on board a seagoing

the vessel, which is located in the port of a State which is not a Member State

The European Union, and if, due to exceptional circumstances it is not possible

place on board the naval facility, which is equipped with a mark of conformity,

You can put the other on board marine equipment, provided that the



and) for maritime equipment is attached documentation issued by the entity,

that is equivalent to the certification, based on the international

the contracts concluded between the European Union and by that State, or



(b)) for maritime equipment is attached documentation certifying the compliance with

the requirements of the International Maritime Organisation (the "IMO") issued by the

a State which is a Contracting Party to international conventions setting out the

the requirements for this device, if the contract is concluded under subparagraph (a))

or if there is no equivalent body in that State.



(2) exceptional circumstances consist in particular of excessive long time

or unreasonably high costs associated with the acquisition of naval

a device provided with a mark of conformity.



(3) the master of a sea-going vessel on board which was located the maritime

the device referred to in paragraph 1, without undue delay, provide the information

listed in the documentation for the device the maritime authority. Without undue delay

After a seagoing vessel arrives at the port in the territory of the European Union,

must be marine equipment referred to in paragraph 1 is replaced by the maritime equipment

provided with a mark of conformity.



(4) If a maritime radio communications device, the device may not cause

adversely on the radio-frequency spectrum.



§ 8



On marine equipment, which had been placed on board a sea-going vessel

before the date of entry into force of this regulation, are not subject to the provisions of

of this regulation.



§ 9



This Regulation shall enter into force on the fifteenth day following the date of its publication.



Prime Minister:



in of PhDr. Cock in r.



Deputy Prime Minister and Minister for Foreign Affairs



Minister of transport:



Ing. Slamečka, MBA in r.



Annex 1



Marine equipment, technical requirements for marine equipment, test

procedures and the conformity assessment procedures to demonstrate compliance with these requirements



1. Marine equipment listed in column 2 of annex a. 1 of Council directive

96/98/EC of 20 May 1999. December 1996 on marine equipment, as amended by

amended, the European Union (hereinafter referred to as "the Directive 96/98/EC").



2. Marine equipment must comply with the technical provisions set out in the

columns 3 and 4 of the annex and of Directive 96/98/EC.



3. Compliance with the requirements referred to in point 2 shall be determined according to the test procedures

standards and conformity assessment procedures set out in columns 5 and 6 of the annex

And Directive 96/98/EC.



4. the provisions amending the annex 1 of Directive 96/98/EC,

apply from the date on which the Member States of the European Union deadline for the

adoption and publication of the provisions necessary to comply with

the EU regulation, which amends this directive. '.



Annex 2



The modules for the conformity assessment and technical documentation



A. conformity assessment modules



1.



EC TYPE-EXAMINATION (MODULE B)



1. the notified body must ascertain and confirm that the sample

representative of the production envisaged, meets the provisions of this

regulation related to this production.



2. the manufacturer or his authorised representative shall obtain from the person

He had chosen, application for EC type-examination. The application must include



— the name and address of the manufacturer and, if the application is lodged by the authorised representative,

his name and address,



-a written declaration that the same application has not been lodged simultaneously with other

the notified body,



— the technical documentation described in point 3.



The applicant shall give the notified body a specimen, representative of

estimated production (hereinafter referred to as "type"). A type may cover several

versions of the product provided that the differences between the versions

do not affect the level of safety and the other requirements concerning the functional

the eligibility of a product. Notified body may request further samples,

If the test programme so requires.



3. the technical documentation must enable the conformity of the product with the

requirements of the relevant provisions of this regulation. The technical documentation

It must, as far as relevant for such assessment, cover the design, construction

building standard, manufacture, installation and operation of the product in accordance with the description

the technical documentation referred to in part B of this annex.



4. the notified body



a) examine the technical documentation and verify that the type has been manufactured in the

conformity with the technical documentation,



b) perform or have performed the appropriate examinations and necessary tests to

determine whether the requirements of this regulation have been met,



(c)) agree with the applicant the location where the examinations and necessary tests

performed.




5. Where the type meets the relevant provisions of this regulation, shall

notified body to issue the EC type-examination certificate to the applicant.

The certificate must contain the name and address of the manufacturer, the details of the

device, conclusions of the examination, conditions for its validity and the data

necessary to identify the approved type. The certificate must be

accompanied by a list of the relevant parts of the technical documentation, and a copy

shall keep the notified body. If the notified body refuses to issue the

EC type-examination certificate to the manufacturer, this fact in detail

reasons for such denial. If a manufacturer reapplies for type-approval of devices,

which has not been issued with the certificate type, you must obtain from the Administration

include all relevant documentation to the person, including the original reports on the

the tests, a detailed statement of the previous refusal and details

all modifications made to the device.



6. The applicant must inform the person that the certification is available

technical documentation concerning the EC type-examination certificate,

all modifications to the approved product which must receive additional

approval where such changes may affect the conformity with the essential

requirements or with the prescribed conditions for use. This

the additional approval shall be given in the form of the Certificate Supplement to the initial EC

type-examination.



7. on request, each notified State authorities of States

the flag of the European Union and other notified parties provide

relevant information concerning the EC type-examination certificate and

additions issued and withdrawn.



8. the other notified the person may receive copies of the EC certificates

type-examination and their additions. The annexes to the certificates must be

kept available to the other notified parties.



9. the manufacturer or his authorised representative must keep with the technical

documentation copies of EC type-examination certificates and their

additions for a period ending at least 10 years from the date of manufacture of the product.



2.



CONFORMITY TO TYPE (MODULE C)



1. the manufacturer or his authorised representative ensures and declares that the

the products concerned are in conformity with the type as described in the EC

type-examination certificate and satisfy the requirements of the provisions of this regulation, which

apply to it. The manufacturer or his authorised representative shall affix each

mark of conformity the product and draw up a written declaration of conformity.



2. The manufacturer shall take all measures necessary in order that the manufacturing process

ensures compliance of the manufactured products with the type as described in the EC

type-examination and with the requirements of the provisions of this regulation, that the

them.



3. the manufacturer or his authorized representative must keep a copy of the Declaration of

conformity for at least 10 years from the date of manufacture of the product.



3.



PRODUCTION QUALITY ASSURANCE (MODULE D)



1. a manufacturer who satisfies the obligations of point 2 ensures and declares

that the products concerned are in conformity with the type as described in the EC

type-examination. The manufacturer or his authorised representative shall affix each

mark of conformity the product and draw up a written declaration of conformity. Brand

matches must be accompanied by the identification number of the notified body

responsible for the surveillance as specified in point 4.



2. the manufacturer must operate an approved quality system for production, final product

product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.



3. Quality System



3.1. the manufacturer must lodge with the notified body, that his choice, the request for

assessment of the quality system for the products concerned. The application must include



and) all relevant information for the product category envisaged,



(b)) the quality system documentation,



(c) the technical documentation of the approved type) and a copy of the certificate of EC

type-examination.



3.2. The quality system must ensure compliance of the products with the type as described in the

EC type-examination certificate. All the elements, requirements and provisions

used by the manufacturer must be documented in a systematic and orderly

form of written measures, procedures and instructions. This documentation system

quality must permit a consistent interpretation of the quality programmes, plans,

quality manuals and quality records. System documentation

It must contain in particular an adequate description of the



a) the quality objectives and the organisational structure, responsibilities and powers

management with regard to product quality,



(b)) of the production process, quality control and quality assurance techniques and

systematic actions that will be used,



c) the examinations and tests that will be carried out before, during

and after manufacture, the frequency with which,



d) quality records, such as inspection reports and results

and test data, calibration data, reports concerning the qualifications of the personnel concerned,



e) means to monitor the achievement of the required quality

products and the efficient operation of the quality system.



3.3. the notified body shall assess the quality system to determine whether the

satisfies the requirements referred to in 3.2. For systems which comply with the relevant

harmonized standard, compliance with these requirements. In the team

Auditors must be at least one member with experience of assessing the

the product technology concerned. The assessment procedure must include an assessment

inspection on the manufacturer's premises. The decision must be notified to the

producers. The notification must contain the conclusions of the examination and the reasoned decision of the

about the assessment.



3.4. the manufacturer shall undertake to fulfil the obligations arising from the

quality system as approved and to maintain it in order to permanently

adequate and efficient. The manufacturer or his authorised representative shall inform the

by a person who has approved the quality system of any intended

updating of the quality system. Notified body shall evaluate the proposed

the changes and decide whether the modified quality system will still satisfy the

requirements referred to in point 3.2 or whether a re-assessment is required.

Notified body shall notify the manufacturer of its decision. The notification must

contain the conclusions of the examination and the reasoned assessment decision.



4. Surveillance under the responsibility of the notified body



4.1. the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.



4



2. The manufacturer shall obtain from the person in order to control access to the

the places of manufacture, inspection, testing and storage, and

provide it with all necessary information, in particular



and) the quality system documentation,



(b)) the quality records, such as inspection reports and results

and test data, calibration data, qualification reports of the relevant

workers.



4.3. the notified body shall periodically carry out audits to make sure that

manufacturer maintains and applies the quality system and to transmit a report on manufacturers

audit.



4.4. Additionally, the notified body the manufacturer

unexpected visits. When such visits

can the notified body, if necessary, carry out or have carried out

tests to verify that the quality system is functioning correctly. Notified body

the person shall provide the manufacturer with a visit report and, if a test

a test report.



5. The manufacturer must, for a period of at least 10 years from the date of manufacture of the product



and) the documentation referred to in 3.1. in subparagraph (b)),



(b)) the updating referred to in second sentence of point 3.4,



(c)), the decisions and reports of the notified body referred to in point 3.4 of the sentence

the fourth and fifth and in points 4.3 and 4.4.



6. each notified body shall, on the request of the public authorities of the States

the flag of the European Union and other notified appropriate persons

for information about system approvals issued and withdrawn.



4.



PRODUCT QUALITY ASSURANCE (MODULE E)



1. a manufacturer who satisfies the obligations of point 2 ensures and declares

that the products concerned are in conformity with the type as described in the EC

type-examination. The manufacturer or his authorised representative shall affix each

mark of conformity the product and draw up a written declaration of conformity. Brand

matches must be accompanied by the identification number of the notified body

responsible for the surveillance as specified in point 4.



2. the manufacturer must operate an approved quality system for final inspection and

testing as specified in point 3 and shall be subject to surveillance as specified in point 4.



3. Quality System



3.1. the manufacturer must lodge with the notified body, that his choice, the request for

assessment of the quality system for the products concerned. The application must include



and) all relevant information for the product category envisaged,



(b)) the quality system documentation,



(c)), where appropriate, the technical documentation the approved type and a copy of the

EC type-examination certificate.



3.2. Each product under the quality system must be checked and must

be made to the appropriate tests in order to ensure compliance with the relevant

the requirements of the provisions of this regulation. All the elements, requirements, and

provisions adopted by the manufacturer must be systematic and orderly

documented in the form of written measures, procedures and instructions. This

the quality system documentation must permit a consistent interpretation of the programs

quality, quality plans, quality manuals and quality records.

The quality system documentation shall contain in particular an adequate description of the



a) the quality objectives and the organisational structure, responsibilities and powers

of the management with regard to product quality,



(b)) the examinations and tests that will be carried out after manufacture,




(c)) the means of supervision of the effective operation of the system

the quality,



d) quality records, such as inspection reports and results

and test data, calibration data, qualification reports of the staff concerned.



3.3. the notified body shall assess the quality system to determine whether the

satisfies the requirements referred to in 3.2. For systems which comply with the relevant

harmonized standard, compliance with these requirements. In the team

Auditors must be at least one member with experience of assessing the

the product technology concerned. The assessment procedure must include an assessment

inspection on the manufacturer's premises. The decision must be notified to the

producers. The notification must contain the conclusions of the examination and the reasoned decision of the

about the assessment.



3.4. the manufacturer shall undertake to fulfil the obligations arising from the

quality system as approved and to maintain it in order to permanently

adequate and efficient. The manufacturer or his authorised representative shall inform the

by a person who has approved the quality system of any intended

updating of the quality system. Notified body shall evaluate the proposed

the changes and decide whether the modified quality system will still satisfy the requirements

referred to in point 3.2 or whether a re-assessment is required. Notified body

shall notify the manufacturer of its decision. The notification must contain the conclusions of the examination and

the reasoned assessment decision.



4. Surveillance under the responsibility of notified body



4.1. the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.



4.2. the manufacturer shall allow the notified person for inspection purposes to the

the space intended for the inspection, testing and storage and provide it with

all necessary information, in particular



and) the quality system documentation,



(b)) the technical documentation,



c) quality records, such as inspection reports and results

and test data, calibration data, qualification reports of the relevant

workers.



4.3. the notified body shall periodically carry out audits to make sure that

manufacturer maintains and applies the quality system and shall provide a report on the

audit.



4.4. Additionally, the notified body the manufacturer

unexpected visits. When such visits

can the notified body, if necessary, carry out or have carried out

tests to verify that the quality system is functioning correctly. Notified body

the person shall provide the manufacturer with a visit report and, if a test

a test report.



5. The manufacturer must, for a period of at least 10 years from the date of manufacture of the product



and) the documentation referred to in point 3.1 (b)),



(b)) the updating referred to in second sentence of point 3.4,



(c)) the decisions and reports of the notified body referred to in the fourth and fifth sentence

point 3.4, point 4.3 and point 4.4.



6. each notified body shall provide, upon request, to government authorities of the State

the flag of the European Union and other notified appropriate persons

information concerning the quality system approvals and withdrawn.



5.



PRODUCT VERIFICATION (MODULE F)



1. the manufacturer or his authorised representative ensures and declares that the

the products referred to in point 3 are in conformity with the type described in the EC

type-examination.



2. The manufacturer shall take all measures necessary in order that the manufacturing process

ensures compliance of the výrodků with the type described in the EC type-examination certificate

type. The manufacturer must affix the mark to each product and draw up a written

the Declaration of conformity.



3. the notified body carry out the appropriate examinations and tests in order to

Verify the conformity of the product with the requirements of the provisions of this regulation, and either

by examination and testing of every product as specified in point 4 or by examination and

testing of products on a statistical basis as specified in point 5.



3.1. The manufacturer or his authorized representative shall keep a copy of the statement

of conformity for at least 10 years from the date of manufacture of the product.



4. Verification by examination and testing of every product



4.1. All products must be individually examined and must be

appropriate tests in order to verify their conformity with the type

as described in the EC type-examination certificate.



4.2. the notified body must affix to each approved product or

Let raise its identification symbol and draw up a written

a certificate of conformity concerning the tests carried out.



4.3. the manufacturer or his authorized representative must be able to

request certificates of conformity certification.



5. Statistical verification



5.1. the manufacturer must present his products in the form of stejnodobých benefits and take

all measures necessary in order that the manufacturing process ensures the uniformity of

each batch produced.



5.2. the verification shall be available for all products in the form of

homogeneous lots. From each batch of the random sample.

Products in a sample shall be individually examined and appropriate

tests in order to check the conformity of the products with the requirements of the provisions of the

This regulation, which applies to them, and to determine whether the lot is

accepted or rejected.



5.3. in the case of accepted lots, the notified body shall affix, or

cause to be affixed, its identification number to each product and draw up a written

certificate of conformity relating to the tests carried out. All products

from the sample may be placed on the market except for those products from the sample

which were found not to match.



If a lot is rejected, the notified body shall take appropriate measures,

to prevent the placing on the market of that lot. In the event of frequent rejection

notified body doses may suspend the statistical verification.



During the production process the manufacturer may affix the responsibility of the

the identification number of the notified body.



5.4. the manufacturer or his authorized representative must be able to

request certificates of conformity certification.



6.



UNIT VERIFICATION (MODULE G)



1. The manufacturer ensures and declares that the product concerned, which has been issued

the certificate referred to in point 2, conforms to the requirements of this regulation, that the

it. The manufacturer or his authorised representative must affix the

mark of conformity and draw up a declaration of conformity.



2. the notified body checks for each individual product and carry out

appropriate tests to ensure its conformity with the provisions of this

of the regulation. Notified body shall affix, or cause to be on the approved product

its identification number and shall issue a certificate of conformity relating to the

the tests carried out.



3. the aim of the technical documentation is to enable conformity with the requirements of

the provisions of this regulation and an understanding of the design, manufacture and

operation of the product.



7.



FULL QUALITY ASSURANCE (MODULE H)



1. a manufacturer who satisfies the obligations of point 2 ensures and declares

that the products concerned satisfy the requirements of the provisions of this regulation which is

to them. The manufacturer or his authorised representative must affix the

mark of conformity and draw up a written declaration of conformity. Conformity mark shall

be accompanied by the identification number of the notified body responsible for the

surveillance as specified in point 4.



2. the manufacturer must operate an approved quality system for design, production, final product

product inspection and testing as specified in point 3 and shall be subject to surveillance as specified in point 4.



3. Quality System



3.1. the manufacturer shall submit for the products concerned by the notified body an application for

assessment of the quality system. The application must include



and) all relevant information for the product category envisaged,



(b) the quality of the documentation).



3.2. The quality system must ensure compliance of the products with the requirements of

the provisions of this regulation that apply to them. All the elements,

requirements and provisions adopted by the manufacturer must be systematically and

orderly manner in the form of written measures, procedures and instructions.

This quality system documentation must permit a consistent interpretation

the quality and procedures such as quality programmes, plans, manuals

quality and quality records. Must contain in particular an adequate description of the



and) the quality objectives and the organisational structure, responsibilities and powers

of the management with regard to design and product quality,



(b)) the technical design specifications, including standards, that will be used, and

in the case where the standards referred to in section 5 are not used fully, the means

that will be used to ensure that the essential requirements of the

This regulation which apply to the products,



c) inspection and design verification techniques, processes and systematic

actions that will be used when designing the products pertaining to the

the product category covered,



(d)) of the respective techniques, processes and systematic actions that will be

used in the manufacture, quality control and quality assurance techniques,



(e)) the examinations and tests that will be carried out before, during

and after production, with an indication of the frequency,



f) quality records, such as inspection reports and results

and test data, calibration data, reports concerning the qualifications of the personnel concerned,



g) means to monitor the achievement of the required quality

designs and products and the efficient operation of the quality system.



3.3. the notified body shall assess the quality system to determine whether the

satisfies the requirements referred to in 3.2. For systems that implement the relevant


harmonized standard, compliance with these requirements. In the team

Auditors must be at least one member with experience of assessing the

the product technology concerned. The assessment procedure must include an assessment

inspection on the manufacturer's premises. The decision must be notified to the

producers. The notification must contain the conclusions of the examination and the reasoned decision of the

about the assessment.



3.4. the manufacturer shall undertake to fulfil the obligations arising from the

quality system as approved and to maintain it in order to permanently

adequate and efficient. The manufacturer or his authorised representative shall inform the

by a person who has approved the quality system of any intended

updating of the quality system. Notified body shall evaluate the proposed

the changes and decide whether the modified quality system will still satisfy the

requirements referred to in point 3.2 or whether a re-assessment is required.

Notified body shall notify the manufacturer of its decision. The notification must

contain the conclusions of the examination and the reasoned assessment decision.



4. Ec surveillance under the responsibility of notified body



4.1. the purpose of surveillance is to ensure that the manufacturer duly fulfils the obligations

arising out of the approved quality system.



4.2. the manufacturer shall allow the notified person for inspection purposes to the

the places of design, manufacture, inspection, testing and

storage and must provide it with all necessary information, in particular



and) the quality system documentation,



(b)) quality records required in part of the quality system relating to

the proposal, such as results of analyses, calculations, tests,



(c)) the quality records provided for in part of the quality system relating to

manufacture, such as inspection reports and test data, about

calibration data, qualification reports of the personnel concerned.



4.3. the notified body shall periodically carry out audits to make sure that

manufacturer maintains and applies the quality system and shall provide a report on the

audit.



4.4. Additionally, the notified body the manufacturer

unexpected visits. When such visits

can the notified body, if necessary, carry out or have carried out

tests to verify that the quality system is functioning correctly. Notified body

the person shall provide the manufacturer with a visit report and, if a test

a test report.



5. The manufacturer must, for a period of at least 10 years from the date of manufacture of the product



and) the documentation referred to in point 3.1 the second sentence of subparagraph (a). (b)),



(b)) the updating referred to in second sentence of point 3.4,



(c)), the decisions and reports of the notified body referred to in point 3.4 of the sentence

the fourth and fifth and in points 4.3 and 4.4.



6. each notified body shall give the other notified parties

the relevant information concerning system approvals issued and withdrawn

the quality.



7. Design examination



7.1. the manufacturer shall lodge an application for examination of the design with a single notified

of the person.



7.2. the application shall enable understanding of the design, manufacture and operation of the product

and the assessment of conformity with the requirements of this regulation. The application must include



and) the technical design specifications, including standards, that will be used,



(b)) the necessary supporting evidence for their adequacy, in particular where

standards referred to in section 5 have not been applied in full. This supporting evidence must

include the results of tests carried out by the appropriate laboratory of the manufacturer

or on behalf of

.



7.3. the notified body shall examine the application and where the design meets the

the provisions of this regulation, which is applicable to it, shall issue to the applicant

EC design examination certificate. The certificate must contain the conclusions of the

of the examination, conditions for its validity, the necessary data for

the identification of the approved design and, where appropriate, a description of the operation of the product.



7.4. The applicant must inform by the person who issued the certificate, the EC

examination of the design of all modifications to the approved design. Changes to the approved

the proposal must be approved by the person who issued the

EC design-examination certificate where they may affect conformity with the

the essential requirements of this regulation or the prescribed conditions for

use of the product. This additional approval in the form of a supplement to the

the original EC design-examination certificate.



7.5. The notified body shall communicate to the other notified the persons concerned

information relating to the



and) EC design-examination certificates and additions issued,



(b)) the EC design-examination certificates it has withdrawn, and amendments thereto.



(B). the technical documentation the manufacturer shall grant the notified person



1. this part of the annex shall apply to all modules.



2. the technical documentation referred to in part A of this annex must include the

all relevant information and the means used by the manufacturer to ensure

the conformity of equipment with the essential requirements which apply to it.



3. the technical documentation shall enable understanding of the design,

manufacture and operation of the product, and shall enable conformity with the requirements of the

the provisions of this regulation.



4. to the extent necessary, the documentation must contain in particular an assessment



and a general description of the type)



(b)) a conceptual design, design standards, manufacturing drawings and diagrams

of components, sub-assemblies, circuits,



c) descriptions and explanations of the drawings and diagrams that are necessary for the

understanding, including product features,



d) results of design calculations carried out independent tests



e) impartial test reports,



f) tutorials for installation, use and maintenance.



5. the dossier of the proposal contains, where appropriate,



and) attestations relating to the equipment incorporated in the appliance,



b) attests and certificates relating to the methods of manufacture and/or inspection

or tracking device,



(c) all other documents allowing) the notified person improve

the assessment.



Annex 3



The requirements for authorization of persons



1. The notified body must carry out the requirements of the relevant standards of the series EN

45 000.



2. The notified body must have its registered office or place of business in the territory of

Of the European Union.



3. A notified body must be independent of all persons directly or

indirectly involved in the development, production, distribution, sales,

installation and maintenance of marine facilities.



4. A notified body, the members of their governing bodies and employees

responsible for conformity assessment shall not participate in any activities that

could endanger the independence of decision-making and objectivity in the assessment of the

of conformity.



5. The notified body must have



a) sufficient number of workers with technical knowledge and

relevant experience in the implementation of the conformity assessment



(b)) the necessary equipment,



in order to enable it to perform properly the activities of bonded with conformity assessment of marine

equipment and ensure a high level of quality.



Annex 4



A graphical representation of the conformity



Mark of conformity must have this form:



If the symbol is reduced or enlarged, must be maintained for the mutual

According to the graduation ratios in the above diagram. Different parts of the brand

must have substantially the same vertical dimension, which may not be less than

5 mm.



For small devices do not need to take into account the minimum size.



Selected provisions of the novel



Article. (II) Government Regulation No. 228/2006.



Transitional provisions



1. on the marine equipment, which was made before the date of entry into force of

This regulation, which, according to the existing legislation, the latter

mark of conformity, are not subject to the provisions of this regulation.



2. Marine equipment, which was made before the date of entry into force of

of this regulation and whose technical requirements not addressed in the regulation

Government No 266/2009 Coll., in the version in force until the date of entry into force of this

Regulation can be placed on the market and put on board a sea-going vessel

not later than 2 years from the date of entry into force of this regulation.



1) Council Directive 96/98/EC of 20 May 1999. December 1996 on marine equipment.



Commission Directive 98/85/EC of 11. November 1998, amending Directive

Of the Council 96/98/EC on marine equipment.



Commission Directive 2002/75/EC of 2 October 1998. September 2002, amending Council directive

Of the Council 96/98/EC on marine equipment.



Directive of the European Parliament and of the Council 2002/84/EC of 5 July 2004. November

2002 amending the directives on maritime safety and prevention

of pollution from ships.



Commission Directive 2008/67/EC of 30 March 2004. June 2008 amending

Council Directive 96/98/EC on marine equipment.



Commission directive 2009/26/EC of 6 May 1999. April 2009 amending

Council Directive 96/98/EC on marine equipment.



Commission directive 2010/68/EC of 22 December 2004. October 2010, amending

Council Directive 96/98/EC on marine equipment.



Commission directive 2011/75/EU of 2. September 2011, amending Directive

Of the Council 96/98/EC on marine equipment.



2) § 2 (2). 2 Act No 61/2000 Coll., on maritime navigation.



3) the negotiation of the Convention, notified under no 52/1995 Sb.



4) section 7A(1). 1 (b). a) and b) of Act No. 64/1986 Coll., on Czech trade

inspection, as amended by Act No. 22/1997 Coll., Act No. 204/2002 Coll. and the

Act No. 228/2003 Coll.